05-3741. General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on April 11, 2005, from 8 a.m. to 5:30 p.m., on April 12, 2005, from 8 a.m. to 6 p.m., and on April 13, 2005, from 8 a.m. to 6 p.m.

Location: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD.

Contact Person: David Krause, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090, ext. 141, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512519. Please call the Information Line or access the Internet address of http://www.fda.gov/​cdrh/​panelmtg.html for up-to-date information on this meeting.

Agenda: On April 11, 2005, the committee will hear oral presentations from the public. On April 12 and 13, 2005, the committee will discuss, make recommendations, and vote on two premarket approval applications for Silicone Gel-Filled Breast Prostheses. Background information, including the agenda and questions for the committee, will be available to the public on April 8, 2005, on the Internet at http://www.fda.gov/​cdrh/​panelmtg.html.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by March 28, 2005. Oral presentations from the public will be scheduled on April 11, 2005, between approximately 8 a.m. and 5:30 p.m., and on April 12 and 13, 2005, between approximately 2:45 p.m. and 3:45 p.m. Time allotted for each presentation is limited. Those desiring to make formal oral presentations should notify the contact person before March 28, 2005, and submit a brief statement of the general nature of the comments they wish to present, and the names and addresses of proposed participants.

Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams, Conference Management Staff, at 240-276-0450, ext. 113, at least 7 days in advance of the meeting.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Dated: February 17, 2005.

Sheila Dearybury Walcoff,

Associate Commissioner for External Relations.